Therapeutic compositions and methods for addressing physiological stresses and aging

ABSTRACT

Therapeutic compositions for addressing physiological stresses and aging include an immune modulator and one or more adaptogenic nutrients. Some non-limiting examples of immune modulators include as transfer factor, low molecular weight fraction immune modulators and/or other low molecular weight fractions of colostrum, egg or any other source of transfer factor or low molecular weight fraction immune modulators. Methods for administering immune modulators and adaptogenic nutrients to a subject to address the effects of physiological stresses and aging in the body of the subject, such as inflammatory responses, are also disclosed.

CROSS-REFERENCE TO RELATED APPLICATION

A claim for the benefit of priority to U.S. Provisional PatentApplication No. 61/890,291, filed on Oct. 13, 2013 and titled“THERAPEUTIC COMPOSITIONS AND METHODS FOR ADDRESSING PHYSIOLOGICALSTRESSES” (“the '291 Provisional Application”) is hereby made pursuantto 35 U.S.C. §119(e). The entire disclosure of the '291 ProvisionalApplication is hereby incorporated herein.

TECHNICAL FIELD

This disclosure relates generally to therapeutic compositions andmethods for addressing physiological stresses and aging. Morespecifically, therapeutic compositions are disclosed that include animmune modulator, such as transfer factor, a low molecular weightfraction immune modulator and/or another low molecular weight fractionof colostrum, egg or any other source of transfer factor or lowmolecular weight fraction immune modulators, and one or more adaptogenicnutrients, as are methods for administering immune modulators andadaptogenic nutrients to a subject to address the effects ofphysiological stresses and aging in the body of the subject.

SUMMARY

In various aspects, the disclosed subject matter relates to compositionsand methods for addressing the effects of physiological stress andaging, as characterized by an increase in inflammation in a subject'sbody and a decrease in the body's detoxifying defenses.

A composition that incorporates teachings of this disclosure may includean immune modulating component and an adaptogenic nutrient component.

Without limitation, the immune modulating component, which is alsoreferred to herein as a “transfer factor component,” may comprisetransfer factor, a low molecular weight fraction immune modulator of thetype disclosed by U.S. Patent Application Publication 2008/0081076 ofLisonbee et al., any other low molecular weight (e.g., 12,000 Da orless) fraction of any source of transfer factor and/or low molecularweight fraction immune modulators (e.g., colostrum, whey, milk, egg, Tlymphocytes (from any animal), etc.), any other immune modulator or anycombination of immune modulators. Each immune modulator may be obtainedfrom a suitable source, such as a mammalian source animal, an aviansource animal, or any other type of animal (e.g., a reptile, anamphibian, etc.). Each immune modulator may be part of an extract thathas been obtained from the source animal. Non-limiting examples includeextracts of colostrum (from mammalian source animals), eggs (from avian,reptilian, amphibian or fish source animals), blood (from any type ofsource animal), tissue (e.g., spleen, liver, marrow, etc.—from any typeof source animal) or the like.

The adaptogenic nutrient component of various embodiments of thedisclosed composition may include one or more adaptogenic nutrients. Asused herein, the term “nutrient” includes, but is not limited to,phytonutrients, such as various herbs. A variety of adaptogenicnutrients may be included in a composition according to this disclosure,and may be selected on the basis of their known or potential effects.Various examples of adaptogenic nutrients that may be included in thecomposition include, but are not limited to, any of the following or,where appropriate, extracts or fractions thereof: Rhaponticumcarthamoides, Schisandra chinensis, Camellia sinensis, Withaniasomnifera, Curcuma longa, Polygonum cusipadatum, Piper nigrum, Panaxquinquefolius, Panax ginseng, Eleutherococcus senticosus, Emblicaofficinalis, Astragalus membranaceus, Cordyceps sinensis, Codonopsispilosula, Tinospora cordifolia, Polygonum multiflorum, Ocimum sanctum,Gynostemma pentaphyllum, Glycyrrhiza glabra, Lycium chinense,Pseudostellaria heterophylla, Ganoderma lucidum, Rhodiola rosea,Asparagus racemosus, shilajit (Asphaltum punjabianum), Takus baccata,Pfaffia paniculata, Vitis vinifera, Silybum marianum, Bacopa monnieri,colostrum, whey, milk and acetyl-1-carnitine HCl.

In some embodiments, a composition may include an immune modulatorcomponent, which is also referred to herein as a transfer factorcomponent, as well as an adaptogenic nutrient component and any of avariety of optional additional ingredients. In other embodiments acomposition may consist essentially of the immune modulator componentand the adaptogenic nutrient component, with non-essential ingredientsincluding oxcipients, vitamins, minerals and the like. In still otherembodiments, the composition may consist of the immune modulatorcomponent and the adaptogenic nutrient component.

Together, the immune modulating component and the adaptogenic nutrientcomponent may address one or more of the effects of physiological stressand/or aging. Accordingly, the adaptogenic nutrients that are includedin the composition may be selected on the basis of their known orpurported ability to address one or more types of physiological stressand/or aging and/or to address one or more of the effects ofphysiological stress and/or aging. Further, the relative proportions ofthe ingredients of a composition according to this disclosure may beformulated, or tailored, to provide a desired response to physiologicalstress and/or aging.

A few examples of physiological stress include the stresses thataccompany poor eating habits (e.g., the consumption of foods that arehigh in fats and/or sugars, etc.), vigorous exercise, overly strenuousor stressful work (e.g., consistently working ten or more hours per day,etc.), lack of sleep, or sleep deprivation (which may vary fromindividual to individual but, in general, may be considered to includesix hours or less sleep per night, on average, etc.), extended travel,exposure to an environmental pollutant, aging, as well as a variety ofother factors. As used herein, the terms “vigorous” and “strenuous,” asrespectively used in conjunction with the terms “exercise” and “work,”and in conjunction with other physical activities implies that anindividual or a subject has performed an above-normal amount of thoseactivities. As an example, any exercise, including new trainingprograms—even training programs that include typically non-vigorous,typically non-strenuous amounts of exercise—may be considered to be“vigorous” for sedentary, untrained subjects. Increases in the amount,or volume, and intensity of a subject's physical activities, incomparison to the levels of those physical activities to which thesubject is accustomed, may also be considered to be “vigorous.”

The effects of physiological stress and/or aging may include an increasein inflammation in the body of a subject (which may be accompanied oreven caused by a variety of factors, such as an increase (e.g., an acuterise, etc.) in inflammatory signaling, including, without limitation,the expression of tumor necrosis factor-α (TNF-α) in the body of asubject, an increase in protein carbonyls in the subject's body, etc.),a decrease in the body's detoxifying defenses (e.g., a decrease in theexpression of mitochondrial superoxide dismutase-2 (SOD-2) in the bodyof the subject, etc.), an increase in central fat mass in a subject'sbody and an increase in the overall mass of the subject's body, to nameonly a few.

In view of the foregoing, a composition may be formulated, or tailored,to: moderate (e.g., reduce, etc.) an inflammatory response by (e.g., anamount of TNF-α, amounts of protein carbonyls, etc., in) a tissue of asubject; moderate (e.g., increase, etc.) a detoxification defense by(e.g., an amount of SOD-2 in) a subject's body; moderate (e.g., slow,reverse, etc.) an increase in central fat stored by the body of thesubject; moderate (e.g., slow, reverse, etc.) an increase in body mass;etc.

One or more immune modulators and one or more adaptogenic nutrients maybe administered in conjunction with one another to address one or moreof the effects of physiological stress and/or aging. Such administrationmay be provided acutely (e.g., one, two or a few doses over a shortperiod of time; a high dose at a specified frequency (e.g., every fourhours, every six hours, every twelve hours, etc.) until an inflammatoryresponse has diminished to an acceptable level, etc.), sub-acutely(e.g., doses over a period of days, etc.) or in a consistent manner overan extended period of time (e.g., daily dosages for a month or longer,etc.). When accompanied by the subject's exposure to physiologicalstress and/or aging, the immune modulator(s) and adaptogenic nutrient(s)can control one or more of the effects of such stress or support healthyaging. When administered after any physiological stress and/or aging onthe subject, the immune modulator(s) and adaptogenic nutrient(s) mayreduce one or more of the effects of such stress.

Other aspects, as well as features and advantages of various aspects, ofthe disclosed subject matter will become apparent to those of ordinaryskill in the art through consideration of the ensuing description andthe appended claims.

DETAILED DESCRIPTION

A composition according to this disclosure includes an immune modulatorcomponent and an adaptogenic nutrient component. The immune modulatorcomponent may include one or more immune modulators, such as transferfactor, a low molecular weight fraction immune modulator, any other lowmolecular weight (e.g., 12,000 Da or less) fraction of any source oftransfer factor and/or low molecular weight fraction immune modulators(e.g., colostrum, whey, milk, egg, T lymphocytes (from any animal),etc.), any other immune modulator or any combination of any of theforegoing. The adaptogenic nutrient component may include a synergisticcombination of adaptogenic nutrients. In some embodiments, thecomposition may also include one or more components that enhance asubject's immune system function, cognitive activity, metabolism,endocrine, liver and/or kidney function, sex hormone and/or sexualfunction, skeletal muscle, cardiorespiratory and/or cardiovascularfunction, human performance, body composition or the like.

In a specific embodiment, a composition that addresses physiologicalstress and/or aging and/or their effects includes, consists essentiallyof or even consists of:

-   -   4Life® Transfer Factor Tri-Factor;    -   Rhaponticum carthamoides extract (root);    -   Schisandra chinensis extract (fruit);    -   ALCAR (as acetyl-1-carnitine HCl);    -   Camellia sinensis (Green Tea) extract (leaf);    -   Withania somnifera (Ashwagandha) extract (root);    -   Curcuminoids (e.g., as Curcuma longa (Turmeric) extract        (rhizome), another turmeric extract or from other sources);    -   Resveratrol (e.g., as Polygonum cuspidatum (or extract (e.g.,        root, etc.) thereof), grape seed (or extract thereof) or from        other sources; and    -   Piperine (e.g., as Piper nigrum (black pepper) (or extract        (e.g., fruit, etc.) thereof) or from other sources).

The composition may comprise an oral dietary supplement. It may besynergistically formulated to promote a more youthful and healthyresponse to advanced aging and/or physiological stresses, such as poordietary habits, vigorous exercise, work (including strenuous work), poorsleeping, aging, exposure to common environmental stressors (e.g., airtravel, environmental pollutants, etc.) or any other physiologicalstress that has negative metabolic and/or biochemical effects. Examplesof such negative metabolic and/or biochemical effects include, but arenot limited to, an inflammatory response and a reduction in the body'sability to detoxify itself. More specifically, the composition may beformulated to moderate inflammation, detoxification or the like. Evenmore specifically, the composition may be formulated to reduce theamount of the proinflammatory mediator, TNF-α in the body of a subject,and to increase the body's ability to fight free radicals. Althoughinflammation is itself a healthy response to a stressful assault on acell, if responded to improperly or left out of control, theinflammatory effects on a cell (and globally, on a subject's body) canbecome problematic. For example, advanced aging, fat gain, muscle loss,poor cognitive and sexual function, and many more such events have allbeen linked to inflammation. By reducing inflammation, the compositionmay help speed the body's natural recovery and improve the agingprocess.

The immune modulating component may include transfer factor, a lowmolecular weight fraction immune modulator of the type disclosed by U.S.Patent Application Publication 2008/0081076 of Lisonbee et al., anyother low molecular weight (e.g., 12,000 Da or less) fraction of anysource of transfer factor and/or low molecular weight fraction immunemodulators (e.g., colostrum, whey, milk, egg, T lymphocytes (from anyanimal), etc.), any other immune modulator or any combination of immunemodulators. Each immune modulator may be obtained from a suitablesource, such as a mammalian source animal or an avian source animal.Each immune modulator may be part of an extract or fraction that hasbeen obtained from the source animal. Non-limiting examples includeextracts of colostrum (from mammalian source animals), eggs (from avian,reptilian, amphibian or fish source animals), blood (from any type ofsource animal), tissue (e.g., spleen, liver, marrow, etc.—from any typeof source animal) or the like.

The adaptogenic nutrients of various embodiments of the disclosedcomposition are targeted to support the immune system, and may be bodysystem-specific. Various examples of adaptogenic nutrients that may beincluded in the composition include, but are not limited to, thefollowing:

Rhaponticum carthamoides, which is also known as Leuzea carthamoides orMaral root, is a flowering herb native to the alpine and subalpineregions of eastern Siberia, as well as in Mongolia, Kazakhstan andnorthwest China (Xingjiang province). R. carthamoides is an approvedadaptogen—a natural substance that is nontoxic, helps the body adapt tostress and/or aging, and has a normalizing effect on the body, helps torestore balance, and supports normal metabolic function—and therefore isgenerally recognized as supporting a wide array of body systemfunctions. R. carthamoides may be included in the composition because ofits adaptogenic herb classification and its previously reported effectson inflammation. Synergistically, R. carthamoides may be included in thecomposition to support immune function and promote healthy aging via itsreported effects on muscle mass, adrenal function and sexual health,which affect recovery, energy and vitality;

Schisandra chinensis, which is also known as Kadsura chinensis orMagnolia vine, is an herb native to several Chinese provinces and is anapproved adaptogen—a natural substance that is nontoxic, helps the bodyadapt to stress and/or aging, and has a normalizing effect on the body,helps to restore balance, and supports normal metabolic function—andtherefore is generally recognized as supporting a wide array of bodysystem functions. S. chinensis may be included in the compositionbecause of its adaptogenic herb classification and its previouslyreported effects on inflammation. Synergistically, S. chinensis may beincluded in the composition to support immune function and promotehealthy aging via its reported effects on liver, kidney and adrenalfunction and sexual health, which affect metabolism, mood, energy,recovery and vitality;

ALCAR (as acetyl-1-carnitine HCl) is a naturally occurring derivative ofthe amino acid, L-carnitine. ALCAR is naturally produced within thebody, primarily within cell mitochondria (primary energy-producingregion of a cell) and peroxisomes (primary fat oxidation region of acell). Mitochondrial density within a cell affects a cell's ability toutilize oxygen and produce energy, and a decrease in mitochondrialdensity contributes to accelerated aging. ALCAR may be included in thecomposition because of its previously reported effects on inflammation,and ability to reduce the amount of TNF-α in a body of a subject and toincrease the amount of SOD2 in the body of the subject. Synergistically,ALCAR may be included in the composition to support immune function andpromote healthy aging via its reported effects on brain andmitochondrial function, and skeletal muscle and cardiovascular health,which affect energy and metabolism;

Camellia sinensis, which is also known as green tea, is widelycultivated but native to tropical and temperate regions of Asia (e.g.,China, India, and Indo-China) and has a long history of human use. C.sinensis may be included in the composition for its previously reportedeffects on inflammation, and ability to reduce TNF-α and increase SOD2.Synergistically, C. sinensis may be included in the composition tosupport immune function and promote healthy aging via its reportedeffects on a wide array of body systems, which affect mood, energy,metabolism, recovery, and vitality;

Withania somnifera (ashwagandha), which is also known as Physalissomnifera or winter cherry, is native to the somewhat drier sub-tropicregions of India, Pakistan, Sri Lanka and parts of Africa. W. somniferais an approved adaptogen. Therefore, W. somnifera is generallyrecognized as supporting a wide array of body system functions. W.somnifera may be included in the composition because of its adaptogenicherb classification and its previously reported effects on inflammation.Synergistically, W. somnifera may be included in the composition tosupport immune function and promote healthy aging via its reportedeffects on adrenal function, sexual health and muscle, which affectrecovery, mood and vitality;

Curcuma longa extract (rhizome), which is also known as turmeric, is amember of the ginger family and is a perennial shrub native to southernAsia and widely cultivated in India, China, Taiwan, Japan, Burma,Indonesia and throughout Africa. Turmeric and other curcuminoids have along history of use, most notably as digestive aids. C. longa or anothersuitable source of curcuminoids may be included in the composition forits curcuminoid active concentration, as curcumnoids are known toprovide beneficial effects on inflammation, on reducing TNF-α and onincreasing SOD2. Synergistically, curcuminoids may be included in thecomposition to support immune function and promote healthy aging via itsreported effects on a wide array of body systems, which affect mood,energy, metabolism, recovery and vitality;

Polygonum cuspidatum, which is also known as Japanese knotweed, is aperennial plant native to eastern Asia, in Japan, China and Korea. P.cuspidatum or any other suitable source of resveratrol may be includedin the composition for its resveratrol active concentration. Resveratrolis known to provide beneficial effects on inflammation, and on reducingTNF-α and increasing SOD2. Synergistically, resveratrol may be includedin the composition to support immune function and promote healthy agingvia its reported effects on a wide array of body systems, which affectmood, energy, metabolism, recovery and vitality; and

Piper nigrum, which is also known as black pepper, is a tropical plantnative to southern India and Sri Lanka. Black pepper and other sourcesof piperine have a long history of use, most notably as a food additivesand digestive aids. P. nigrum or any other suitable source of piperinemay be included in the composition for having a piperine activeconcentration that provides beneficial effects on inflammation, and onreducing TNF-α and increasing SOD2. Synergistically, piperine may beincluded in the composition to support immune function and promotehealthy aging via its reported effects on a wide array of body systems,which affect mood, energy, metabolism, recovery and vitality.

A composition according to this disclosure may be administered in any ofa variety of ways. As an alternative to administering a composition thatincludes an immune modulating component and an adaptogenic nutrientcomponent, an immune modulator and a blend of adaptogenic nutrients maybe administered to the subject. For the sake of simplicity, both thecomposition and the separate components are referred to hereinafter as acomposition. As a non-limiting example, one serving of the compositionmay be administered twice each day, on an empty stomach first thing inthe morning and again about six hours to about eight hours later. Asanother non-limiting example, a subject may take three or four servingsof the composition each day, particularly when the subject is subjectedor will be subjected to an above-normal amount of physiological stress(e.g., before exercise, immediately after exercise, while traveling,etc.). The composition may be administered with one or more othernutritional supplements (e.g., 4LIFE® TRANSFER FACTOR®, a multivitamin,fish oil and/or a probiotic, etc.).

EXAMPLE COMPOSITION

A specific embodiment of the composition includes, consists essentiallyof or consists of the following ingredients in one or more of the perserving amounts listed below:

-   -   4Life® TRANSFER FACTOR® TRI-FACTOR® (25 mg to 500 mg; about 25        mg; about 50 mg; about 75 mg; about 100 mg; about 150 mg; about        250 mg; etc.);    -   Rhaponticum carthamoides extract (root) (≧5% total ecdysteroids)        (50 mg to 2,000 mg; 200 mg to 300 mg; about 200 mg; about 225        mg; about 250 mg; about 275 mg; about 300 mg; about 500 mg;        etc.);    -   Schisandra chinensis extract (fruit) (≧2% total schisandrins)        (50 mg to 2,000 mg; 200 mg to 300 mg; about 200 mg; about 225        mg; about 250 mg; about 275 mg; about 300 mg; about 500 mg;        etc.);    -   ALCAR (as acetyl-1-carnitine HCl) (50 mg to 2,000 mg; 200 mg to        300 mg; about 200 mg; about 225 mg; about 250 mg; about 275 mg;        about 300 mg; about 500 mg; etc.);    -   Camellia sinensis (green tea) extract (leaf) (≧45% EGCG) (25 mg        to 2,000 mg; 200 mg to 300 mg; about 200 mg; about 225 mg; about        250 mg; about 275 mg; about 300 mg; about 500 mg; etc.);    -   Withania somnifera (ashwagandha) extract (root) (≧5% total with        anolides) (25 mg to 500 mg; about 25 mg; about 50 mg; about 75        mg; about 100 mg; about 150 mg; about 250 mg; etc.);    -   Curcuma longa (turmeric) extract (rhizome) (≧95% curcuminoids)        (10 mg to 500 mg; about 25 mg; about 50 mg; about 75 mg; about        100 mg; about 150 mg; about 250 mg; etc.);    -   Polygonum cuspidatum extract (root) (≧50% resveratrol) (5 mg to        500 mg; about 25 mg; about 50 mg; about 75 mg; about 100 mg;        about 150 mg; about 250 mg; etc.); and    -   Piper nigrum (black pepper) extract (fruit) (≧95% piperine) (2.5        mg to 500 mg; about 25 mg; about 50 mg; about 75 mg; about 100        mg; about 150 mg; about 250 mg; etc.).

EXAMPLE

As an example of its potential efficacy in addressing effects ofphysiologic stress and/or aging, a composition according to thisdisclosure was administered to adult rodents in a recent randomized,placebo-controlled, linearly designed safety and efficacy study,conducted at the University of Missouri, Department of BiomedicalSciences (Columbia, Mo.) and in collaboration with Auburn UniversityDepartment of Kinesiology (Auburn, Ala.). The human equivalent of two(2) servings per day of an EXAMPLE COMPOSITION was administered to eachadult rodent of a test group for 30 days, and was demonstrated tosignificantly reduce the adverse effects observed in response to atypical inflammation-inducing Westernized diet (high-fat, high-sugar).Specifically, the EXAMPLE COMPOSITION significantly reduced theinflammatory response to a Westernized diet by 64% (measured as tumornecrosis factor-alpha, or TNF-α expression). The EXAMPLE COMPOSITIONalso provided a 42% reduction in the oxidative damage caused to cellularproteins (measured as protein carbonyl concentration) and a 43% increasein the detoxifying enzyme responsible for reducing the damage caused byfree radicals (measured as mitochondrial superoxide dismutase-2, orSOD2). The EXAMPLE COMPOSITION plus a Westernized diet even resulted ina 57% lower inflammatory response than just consuming a healthy low-fat,low-sugar control diet alone. The EXAMPLE COMPOSITION plus a Westernizeddiet significantly reduced the oxidative damage to cellular proteins by53%, and increased the presence of detoxifying SOD2 by over 74% versus ahealthy control diet only group. Additionally, a Westernized diet plusthe EXAMPLE COMPOSITION significantly reduced the accumulation ofcentral (or visceral) fat mass by 6% and body mass by 95% versus theunhealthy diet treatment alone. Blood chemistry and liver histopathologydata also revealed that the human equivalent of two servings per day ofthe EXAMPLE COMPOSITION for 30 days, presents no signs of adversesafety.

Some of these results are set forth in the following table:

DOSE OF SUBSTANTIATED SERVING SERVINGS ACTIVE SIZE per DAYSTRUCTURE-FUNCTION CLAIMS* INGREDIENT(S) REFERENCE(s) 2 caps 2 Ahigh-fat, high-sugar inflammatory diet + an EXAMPLE 2 servings perMobley, C.B., et COMPOSITION resulted in a significant decrease in liverday ×30 days al, “Effects of TNF-α (−64%) versus a high-fat, high-sugardiet alone of an EXAMPLE herbal A high-fat, high-sugar inflammatorydiet + an EXAMPLE COMPOSITION adaptogens COMPOSITION resulted in a 43%increase in liver mito- (Human dose combined with chondria SOD2 versus ahigh-fat, high-sugar diet alone equivalent; study protein fractions Ahigh-fat, high-sugar inflammatory diet + an EXAMPLE in adult rats) frombovine COMPOSITION resulted in reduced liver Protein Carbonylscolostrums and (−42%) versus a high-fat, high-sugar diet alone hen eggyolk on A high-fat, high-sugar inflammatory diet + an EXAMPLE markers ofCOMPOSITION resulted in a significantly reduced increase ininflammation, Central (or Visceral) Fat Mass (−6%) versus a high-fat,high- liver health, and sugar diet alone antioxidant A high-fat,high-sugar inflammatory diet + an EXAMPLE status following COMPOSITIONresulted in a significantly reduced increase in high fat/high Body Mass(−95%) versus a high-fat, high-sugar diet alone sucrose diet A high-fat,high-sugar inflammatory diet + an EXAMPLE feeding in rats,” COMPOSITIONresulted in a 57% decrease in liver TNF-α Nutr. Metab. versus a healthycontrol diet alone (2014) (In A high-fat, high-sugar inflammatory diet +an EXAMPLE review). COMPOSITION resulted in a 53% decrease in thepresence of liver Protein Carbonyls versus a healthy control diet aloneA high-fat, high-sugar inflammatory diet + an EXAMPLE COMPOSITIONresulted in a 74% increase in liver mitochondria SOD2 versus a healthycontrol diet alone Research evidence suggests that an EXAMPLECOMPOSITION may decrease the inflammatory response to an unhealthy dietby as much as 64% Research evidence suggests that an EXAMPLE COMPOSITIONmay increase the body's detoxifying defenses in response to an unhealthydiet by as much as 74% Research evidence suggests that an EXAMPLECOMPOSITION may decrease the oxidative damage caused by an unhealthydiet by as much as 42% Research evidence suggests that an EXAMPLECOMPOSITION may decrease the inflammatory response to a typical stressby as much as 64% Research evidence suggests that an EXAMPLE COMPOSITIONmay increase the body's detoxifying defenses in response to a typicalstress by as much as 74% Research evidence suggests that an EXAMPLECOMPOSITION may decrease the oxidative damage caused by a typical stressby as much as 42% Research evidence suggests that an EXAMPLE COMPOSITIONdoes not cause any adverse events or possess any serious safety riskswhen used as directed for 30 days *Claims are additive; claims are notrepeated as the number of “Servings Per Day” increases

Although the foregoing description sets forth many specifics, theseshould not be construed as limiting the scope of any of the claims, butmerely as providing illustrations of some embodiments and variations ofelements or features of the disclosed subject matter. Other embodimentsof the disclosed subject matter may be devised which do not depart fromthe spirit or scope of any of the claims. Features from differentembodiments may be employed in combination. Accordingly, the scope ofeach claim is limited only by its plain language and the legalequivalents thereto.

What is claimed is:
 1. A method for addressing an inflammatory responseby a body of a subject to a physiological stress, comprising: subjectinga body of a subject to a physiological stress that causes an increase inan inflammatory response by the body; and within a predetermined periodof time before, during or within a predetermined period of time aftersubjecting the body of the subject to the physiological stress,administering an immune modulator and a blend of adaptogenic nutrientcomponents to the subject, the blend of adaptogenic nutrient componentsconsisting essentially of Rhaponticum carthamoides extract, Schisandrachinensis extract, acetyl-1-carnitine HCl, Camellia sinensis extractWithania somnifera extract, a source of a curcuminoid, a source ofresveratrol, and a source of piperine, the immune modulator and theblend of adaptogenic nutrient components moderating the inflammatoryresponse by the body of the subject.
 2. The method of claim 1, whereinsubjecting the body of the subject to the physiological stress comprisessubjecting the body of the subject to at least one of an inflammatorydiet, strenuous work hours, vigorous exercise, sleep deprivation,extended travel, aging or an environmental pollutant.
 3. The method ofclaim 1, wherein administering is effected over a period of at least onemonth and further includes moderating a central fat mass of the body ofthe subject.
 4. The method of claim 1, wherein administering is effectedover a period of at least one month and further includes moderating abody mass of the body of the subject.
 5. The method of claim 1, whereinadministering is effected acutely.
 6. The method of claim 1, wherein:subjecting comprises increasing an amount of at least one of tumornecrosis factor-α and protein carbonyls in the body of the subject; andadministering includes moderating an amount of at least one of the tumornecrosis factor-α and protein carbonyls in the body of the subject. 7.The method of claim 6, wherein moderating includes decreasing the amountof at least one of tumor necrosis factor-α and protein carbonyls in thebody of the subject.
 8. The method of claim 1, wherein administeringfurther includes administering a low molecular weight fraction immunemodulator to the subject.
 9. A method for addressing an inflammatoryresponse by a body of a subject to a physiological stress or as acharacteristic of advanced aging, comprising: subjecting a body of asubject to a physiological stress that causes a decrease in adetoxifying defense by the body; and within a predetermined period oftime before, during or within a predetermined period of time aftersubjecting the body of the subject to the physiological stress,administering an immune modulator and a blend of adaptogenic nutrientcomponents to the subject, the blend of adaptogenic nutrient componentsconsisting essentially of Rhaponticum carthamoides extract, Schisandrachinensis extract, acetyl-1-carnitine HCl, Camellia sinensis extract,Withania somnifera extract, a source of a curcuminoid, a source ofresveratrol, and a source of pipeline the immune modulator and the blendof adaptogenic nutrient components moderating the detoxifying defense bythe body of the subject.
 10. The method of claim 9, wherein: subjectingcomprises decreasing an amount of mitochondrial superoxide dismutase-2in the body of the subject; and administering comprises moderating theamount of mitochondrial superoxide dismutase-2 in the body of thesubject.
 11. The method of claim 10, wherein moderating includesincreasing the amount of mitochondrial superoxide dismutase-2 in thebody of the subject.
 12. The method of claim 9, wherein administeringfurther includes administering a low molecular weight fraction immunemodulator to the subject.
 13. A method for addressing an inflammatoryresponse by a body of a subject to a physiological stress, comprising:subjecting a body of a subject to a physiological stress that causes anincrease in an inflammatory response by the body; and within apredetermined period of time before, during or within a predeterminedperiod of time after subjecting the body of the subject to thephysiological stress, administering an immune modulator and a blend ofadaptogenic nutrient components to the subject, the immune modulatorcomprising a source of transfer factor, the blend of adaptogenicnutrient components consisting essentially of Rhaponticum carthamoidesextract Schisandra chinensis extract, acetyl-1-carnitine HCl, Camelliasinensis extract, Withania somnifera extract, a source of a curcuminoid,a source of resveratrol, and a source of piperine, the immune modulatorand the blend of adaptogenic nutrient components moderating theinflammatory response by the body of the subject.
 14. The method ofclaim 13, wherein administering comprises administering a 12,000 D orless fraction of the immune modulator to the subject.
 15. The method ofclaim 13, wherein administering comprises administering an immunemodulator comprising colostrum to the subject.
 16. The method of claim13, wherein administering comprises administering an immune modulatorcomprising avian egg to the subject.